Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer L…
restor3d Inc. · (Retroactively reported) Pairing of shoulder implant stem sizes 1 and 2 with the largest glenosphere diameter (40 mm) creates an excessive mechanical loading c…
Open FDA's page for this record- Cfres ID
- 223193
- Product res number
- Z-0348-2027
- Event date initiated
- 2026-10-01
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 100047
- Product code
- PHX
- Product description
- Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
- Firm FEI number
- 3014833750
- Recalling firm
- restor3d Inc.
- Address 1
- 4001 E Nc 54 Hwy
- Address 2
- Suite 3160
- City
- Durham
- State
- NC
- Postal code
- 27709
- Additional info contact
- Brianna Gabbard 1-786-5210501
- Root cause description
- Device Design
- Product quantity
- 240 units
- Distribution pattern
- US Nationwide distribution in the states of Texas, Massachusetts, Oklahoma, Florida, Colorado, North Carolina.
- Code info
All Lot codes/ UDIs:Product Code: 3500-140C3 UDI/GTIN:00840097513492; Product Code: 3500-140U3 UDI/GTIN:00840097513461; Product Code: 3500-140C1 UDI/GTIN:00840097513430; Product Code: 3500-140U1 UDI/GTIN:00840097513409
- Reason for recall
(Retroactively reported) Pairing of shoulder implant stem sizes 1 and 2 with the largest glenosphere diameter (40 mm) creates an excessive mechanical loading configuration in which certain polyethylene components lack adequate retention strength, potentially resulting in dislocation, reduced range of motion, or revision surgery.
- Action
On 1, 2026 Restor3d reached out to affected consignees via phone call to make them aware of the recall. A Urgent; Medical Device Recall was issued to affected consignees on October 7, 2026 via email. Restor3d ask consignees to take the following actions: 1. Do not implant or otherwise use any affected units identified above. 2. Complete the attached Field Action Response Form (Attachment A) and return it to restor3d within 10 business days, so that restor3d can confirm effective distribution of this notice. 3. Promptly report to restor3d any intraoperative issue, patient adverse event, suspected device related complication, loosening, migration, revision surgery, or other clinical concern potentially associated with the affected product.
- K numbers
- K243643
- Harmonized identifiers (openFDA)
- Device name
- Shoulder Prosthesis, Reverse Configuration
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3660
- Device class
- 2
- K number
- K171789, K252404, K200895, K113121, K202098, K212415, K130895, K181611, K050315, K080642, K241043, K183077, K203694, K252352, K252516, K041873, K092900, K252788, K213117, K181999, K142863, K231445, K232265, K120374, K110708, K111735, K161742, K140082, K192799, K253624, K072804, K131575, K161120, K211991, K203755, K250338, K132285, K140478, K152754, K260102 +167 more
- Registration number
- 8010916, 1043534, 1835444, 3008534770, 9617840, 3006563559, 3009923578, 3012544635, 3014128390, 3004748528, 8010379, 3011274144, 3009423112, 3009555440, 3017036078, 3010065126, 1834379, 1219655, 3006272282, 3009971621, 1526534, 3007441485, 1529009, 3003403260, 3011500362, 3006017180, 3010009693, 1836357, 9616671, 1423662, 3005562917, 3008421730, 3009532798, 3010370880, 3008388276, 3004153896, 3019269298, 1450662, 3010386387, 2528981 +153 more
- FEI number
- 3003386935, 1043534, 3002807830, 3002807036, 3003064967, 3008534770, 1000220733, 3006563559, 3009923578, 3012544635, 3014128390, 3004748528, 3011274144, 3009423112, 3009555440, 3017036078, 3001814066, 1000306431, 3010065126, 1219655, 3006272282, 1000116116, 1526534, 3009971621, 3007441485, 3001452082, 3003403260, 3002854251, 3011500362, 3006017180, 3010009693, 3005562917, 3005233524, 3008421730, 3009532798, 3010370880, 3008388276, 3004153896, 3019269298, 3002924544 +153 more